Dispensing Fluid from an Infusion Pump System

ABSTRACT

Some embodiments of a medical infusion pump system include a pump device having a flexible pushrod that can adjust from a curved configuration to a generally straight configuration. The flexible pushrod is part of a drive system of the pump device so that the flexible pushrod can be controllably and incrementally advanced toward a medicine reservoir to incrementally dispense the medicine therein. In particular embodiments, the flexible pushrod may comprise an anti-rotation mechanism, an anti-torsion mechanism, or a combination thereof.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. application Ser. No. 13/358,330filed on Jan. 25, 2012 by Mernoe et al., which is a division of U.S.application Ser. No. 11/522,836 filed on Sep. 18, 2006 by Mernoe et al.,which claims priority to each of: (1) U.S. Provisional Application Ser.No. 60/720,411 filed on Sep. 26, 2005 by Mernoe et al. and entitled“Precision Drive Mechanism,” (2) U.S. Provisional Application Ser. No.60/720,405 filed on Sep. 26, 2005 by Mernoe et al. and entitled“Flexible Pushrod Mechanism,” and (3) U.S. Provisional Application Ser.No. 60/721,267 filed on Sep. 28, 2005 by Estes et al. and entitled“Infusion Pump with Removable Controller.” The contents of thesepreviously filed applications are fully incorporated by referenceherein.

TECHNICAL FIELD

This document relates to an infusion pump system, such as a medicalinfusion pump system.

BACKGROUND

Pump devices are commonly used to deliver one or more fluids to atargeted individual. For example, a medical infusion pump device may beused to deliver a medicine to a patient as part of a medical treatment.The medicine that is delivered by the infusion pump device can depend onthe condition of the patient and the desired treatment plan. Forexample, infusion pump devices have been used to deliver insulin to thevasculature of diabetes patients so as to regulate blood-glucose levels.

A number of factors may affect the design of infusion pump devices. Onesuch factor is the size of the device. The pump device may be sized tohouse the various pump components, yet a large device may reduce theportability options and convenience for the user. A number of infusionpump components can impact the overall size and portability of aninfusion pump system and the convenience to the user. For example, if apump device includes a straight, rigid pushrod to force medicine fromthe infusion pump device, the pump housing is typically sized toaccommodate the length of the rigid rod both when it is fully withdrawnfrom the reservoir and when it is fully extended into the reservoir.

SUMMARY

Some embodiments of a medical infusion pump system include a pump devicehaving a pushrod that can adjust from a curved configuration to agenerally straight configuration. The pushrod is part of a drive systemof the pump device so that the pushrod can be controllably andincrementally advanced toward a medicine reservoir to incrementallydispense the medicine therein. In particular embodiments, the pushrodmay comprise an anti-rotation mechanism, an anti-torsion mechanism, ananti-elongation mechanism, or a combination thereof.

In some embodiments, an infusion pump system for the delivery ofmedication may include a pump housing that defines a space to receive amedicine for dispensation and a drive system to dispense medicine whenthe medicine is received by the pump housing. The drive system mayinclude a pushrod that is movable to apply a dispensing force todispense medicine. The pushrod may include rod segments, and each rodsegment may interconnected to the next rod segment by a hinge portion sothat at least a portion of the pushrod is adjustable from a curved shapeto a generally noncurved shape. The pushrod may also include ananti-rotation mechanism to oppose rotation of the pushrod about alongitudinal axis of the pushrod. The pushrod may further include ananti-torsion mechanism to oppose torsion of one rod segment relative toanother rod segment.

Particular embodiments of an infusion pump system for the delivery ofmedication may include a pump housing that defines a space to receive amedicine for dispensation and a drive system to dispense medicine whenthe medicine is received by the pump housing. The drive system mayinclude a pushrod that is movable to apply a dispensing force todispense medicine. The pushrod may include rod segments that arehingedly engaged to one another such that at least a portion of thepushrod is adjustable from a curved shape to a generally noncurvedshape. The pushrod may also include an anti-rotation mechanism to hinderrotation of the pushrod about a longitudinal axis of the pushrod. Theanti-rotation mechanism may include two or more longitudinal channelsextending through at least a plurality of the rod segments.

Some embodiments of an infusion pump system for the delivery ofmedication may include a pump housing that defines a space to receive amedicine for dispensation and a drive system to dispense medicine whenthe medicine is received by the pump housing. The drive system mayinclude a pushrod that is movable to apply a dispensing force todispense medicine. The pushrod may include rod segments that arehingedly engaged to one another such that at least a portion of thepushrod is adjustable from a curved shape to a generally noncurvedshape. The pushrod may include an anti-torsion mechanism to opposetorsion of one rod segment relative to an adjacent rod segment. Theanti-torsion mechanism may include an extended member protruding fromthe one rod segment that is engageable with a cavity disposed in theadjacent rod segment.

Certain embodiments of an infusion pump system for the delivery ofmedication may include a pump housing that defines a space to receive amedicine for dispensation and a drive system to dispense medicine whenthe medicine is received by the pump housing. The drive system mayinclude a pushrod that is movable to apply a dispensing force todispense medicine. The pushrod may include rod segments that arehingedly engaged to one another such that at least a portion of thepushrod is adjustable from a curved shape to a generally noncurvedshape. The pushrod may include an anti-elongation mechanism disposed onat least a plurality of the pushrod segments to maintain the leadingface of one pushrod segment in abutting relationship with a trailingface of an adjacent pushrod segment when a portion of the pushrod isadjusted to the generally noncurved shape.

In some embodiments, an infusion pump system for the delivery ofmedication may include a pump housing that defines a space to receive amedicine for dispensation and a drive system to dispense medicine whenthe medicine is received by the pump housing. The drive system mayinclude a pushrod that is movable to apply a dispensing force todispense medicine. The pushrod may include rod segments that arehingedly engaged to one another such that at least a portion of thepushrod is adjustable from a curved shape to a generally noncurvedshape. Each of the hinge portions may comprise a flexible wire thatextends from a leading face of one rod segment to a trailing face of anadjacent rod segment.

Some embodiments of an infusion pump system for the delivery ofmedication may include a pump housing that defines a space to receive amedicine for dispensation and a drive system to dispense medicine whenthe medicine is received by the pump housing. The drive system mayinclude a pushrod that is movable to apply a dispensing force todispense medicine. The pushrod may include mechanically assembled rodsegments. Each rod segment may include a hinge protrusion that pivotablyengages a hinge receiver cavity of the next rod segment in the row by ahinge assembly so that at least a portion of the pushrod is adjustablefrom a curved shape to a generally noncurved shape.

These and other embodiments may provide one or more of the followingadvantages. First, the infusion pump system may be portable so that auser can wear the pump device (e.g., adhered to the user's skin orcarried in a user's pocket or portion of clothing) and receive theinfused medicine throughout the day or night. Second, the pump device ofthe infusion pump system may include a drive system that controllablydispenses medicine in a reliable manner. Third, the pump device of theinfusion pump system can be removably attached to a controller devicehaving a user interface. As such, the user can readily monitor theoperation of the pump device without the need for carrying and operatingan separate wireless module. Fourth, some embodiments of the pump devicecan include a pushrod that is flexible. For example, the pushrod maycomprise rod segments interconnected by hinge portions that permitportions of the pushrod to adjust from a curved shape to a generallynoncurved shape. Fifth, the pushrod may be equipped with ananti-rotation mechanism that opposes rotation of the pushrod about itslongitudinal axis. In these circumstances, the pushrod is hindered fromrotating when a drive wheel or the like rotates about the wheel axis.Sixth, the pushrod may be equipped with an anti-torsion mechanism thatopposes torsion of one pushrod segment relative to another pushrodsegment. Accordingly, the anti-torsion mechanism can oppose the torsionstress across the hinge portions during operation of the drive system.Seventh, the pushrod may be equipped with an anti-elongation mechanismthat maintains a portion of the pushrod in a rigid condition after thatportion of the pushrod has been adjusted to the generally noncurvedshape. Such an anti-elongation mechanism may reduce the likelihood ofincidental dispensation of medicine with the pump device undergoes animpact (e.g., when the pump device is dropped on the ground).

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an infusion pump system, in accordancewith some embodiments.

FIG. 2 is another perspective view of the infusion pump system of FIG.1.

FIG. 3 is another perspective view of the infusion pump system of FIG.1.

FIG. 4 is an exploded perspective view of the infusion pump system ofFIG. 1.

FIG. 5 is a perspective view of a controller device of the infusion pumpsystem of FIG. 1.

FIG. 6 is a perspective view of one controller device of the infusionpump system of FIG. 5.

FIG. 7 is an exploded view of a pump device of the infusion pump systemof FIG. 1.

FIG. 8 is an exploded view of a portion of the pump device of theinfusion pump system of FIG. 7.

FIG. 9 is a perspective view of a portion of a drive system of the pumpdevice of FIG. 8.

FIG. 10 is a perspective view of a portion of a flexible pushrod of thedrive system of FIG. 9.

FIG. 11 is a cross-sectional view of the portion of the drive system ofFIG. 9.

FIG. 12 is a section view of a portion of the pump device of FIG. 8.

FIGS. 13A-B is a perspective view of a portion of a flexible pushrod inaccordance with some embodiments.

FIG. 14 is a perspective view of a portion of a flexible pushrod inaccordance with some embodiments.

FIG. 15 is a perspective view of a portion of a flexible pushrod inaccordance with some embodiments.

FIG. 16 is a perspective view of a portion of a flexible pushrod inaccordance with some embodiments.

FIGS. 17A-B are perspective views of a portion of the flexible pushrodof FIG. 16.

FIG. 18 is a perspective view of a flexible pushrod in accordance withsome embodiments.

FIGS. 19-20 are perspective views of a flexible pushrod in accordancewith some embodiments.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIGS. 1-2, some embodiments of an infusion pump system 10include a pump device 100 that can communicate with a controller device200. The pump device 100 includes a housing structure 110 that defines acavity 116 in which a fluid cartridge 120 is received. In thisembodiment, the pump system 10 in a medical infusion pump system that isconfigured to controllably dispense a medicine from the cartridge 120.As such, the fluid cartridge 120 may contain a medicine to be infusedinto the tissue or vasculature of a targeted individual, such as a humanor animal patient. For example, the pump device 100 can be adapted toreceive a medicine cartridge 120 in the form of a carpule that ispreloaded with insulin or another medicine for use in the treatment ofDiabetes (e.g., Byetta®, Symlin®, or others). Such a cartridge 120 maybe supplied, for example, by Eli Lilly and Co. of Indianapolis, Ind.Other examples of medicines contained in the fluid cartridge 120include: pain relief drugs, hormone therapy, blood pressure treatments,anti-emetics, osteoporosis treatments, or other injectable medicines.

In some embodiments, the controller device 200 may be removably attachedto pump device 100 so that the two components are mechanically mountedto one another. Such a mechanical attachment can secure an electricalconnection between the removable controller device 200 and the pumpdevice 100. For example, the controller device 200 may be in electricalcommunication with a portion of a drive system (not shown in FIGS. 1-2)of the pump device 100. As described in more detail below, the pumpdevice 100 includes a drive system that causes controlled dispensationof the medicine or other fluid from the cartridge 120. In someembodiments, the drive system incrementally advances a pushrod (refer,for example, to FIG. 7) longitudinally into the cartridge 120 so thatthe fluid is force out of the output end 122. In this embodiment, theseptum at the output end 122 can be pierced to permit fluid outflow whena cap member 115 is connected to the pump housing structure 110(described in more detail below, for example, in connection with FIG.5). Thus, when the pump device 100 and the controller device 200 areremovably attached and thereby electrically connected, the controllerdevice 200 communicates electronic control signals viahard-wire-connection to the drive system or other components of the pumpdevice 100. In response to the electrical control signals from thecontroller device 200, the drive system of the pump device 100 causesmedicine to incrementally dispense from the medicine cartridge 120.

Still referring to FIGS. 1-2, The controller device 200 can include acontroller housing structure 210 that is configured to mate with acomplementary portion of the pump housing structure 110 so as to form areleasable mechanical connection. For example, the controller housingstructure 210 may define a cavity (refer, for example, to FIG. 6) thatmates with a portion of the pump housing structure 110 for a snap fitengagement. Also, the controller housing structure 210 may include afinger 212 that engages a mating surface 117 of the pump housingstructure 110 when the controller device 200 is removably attached tothe pump device 100. As described in more detail below in connectionwith FIGS. 4-5, a magnetic attachment may be employed to releasablysecure the pump device 100. For example, the magnetic attachment canserve to retain the pump housing structure 110 in the cavity defined bythe controller housing structure 210. In alternative embodiments, one ormore releasable connector devices (e.g., mating tongues and grooves,mounting protrusions friction fit into mating cavities, or the like) canbe used to further implement the releasable securement of the controllerdevice 200 to the pump device 100.

As described in more detail below in connection with FIGS. 4-5, the pumpdevice 100 may include one or more electrical contacts (e.g., conductivepads, pins, and the like) that are exposed to the controller device 200and that mate with complementary electrical contacts on the adjacentface of the controller device 200. The electrical contacts provide theelectrical communication between the control circuitry of the controllerdevice 200 and at least a portion of the drive system or othercomponents of the pump device 100. For example, in some embodiments, theelectrical contacts permit the transmission electrical control signalsto the pump device 100 and the reception of feedback signals (e.g.,sensor signals) from particular components within the pump device 100.

Still referring to FIGS. 1-2, the controller device 200 includes a userinterface 220 that permits a user to monitor the operation of the pumpdevice 100. In some embodiments, the user interface includes a display222 and one or more user-selectable buttons (e.g., four buttons 224 a,224 b, 224 c, and 224 d in this embodiment). The display 222 may includean active area 223 in which numerals, text, symbols, images, orcombination thereof can be displayed. For example, the display 222 maybe used to communicate a number of settings or menu options for theinfusion pump system 10. In this embodiment, the user may press one ormore of the buttons 224 a, 224 b, 224 c, and 224 d to shuffle through anumber of menus or program screens that show particular settings anddata (e.g., review data that shows the medicine dispensing rate, thetotal amount of medicine dispensed in a given time period, the amount ofmedicine scheduled to be dispensed at a particular time or date, theapproximate amount of medicine remaining the cartridge 120, or thelike). As described in more detail below, in some embodiments, the usercan adjust the settings or otherwise program the controller device 200by pressing one or more buttons 224 a, 224 b, 224 c, and 224 d of theuser interface 220. In embodiments of the infusion pump system 10configured to dispense insulin, the user may press one or more of thebuttons 224 a, 224 b, 224 c, and 224 d to change the dispensation rateof insulin or to request that a bolus of insulin be dispensedimmediately or at a scheduled, later time.

As shown if FIG. 1, the display 222 of the user interface 220 may beconfigured to display quick reference information when no buttons 224 a,224 b, 224 c, and 224 d have been pressed. In this example, the activearea 223 of the display 222 can display the time and the date for aperiod of time after no button 224 a, 224 b, 224 c, or 224 d has beenactuated (e.g., five seconds, 10 seconds, 30 seconds, 1 minute, 5minutes, or the like). Thereafter, the display 222 may enter sleep modein which the active area 223 is blank, thereby conserving battery power.In addition or in the alternative, the active area can displayparticular device settings, such as the current dispensation rate or thetotal medicine dispensed, for a period of time after no button 224 a,224 b, 224 c, or 224 d has been actuated (e.g., five seconds, 10seconds, 30 seconds, 1 minute, 5 minutes, or the like). Again,thereafter the display 222 may enter sleep mode to conserve batterypower. In certain embodiments, the display 222 can dim after a firstperiod of time in which no button 224 a, 224 b, 224 c, or 224 d has beenactuated (e.g., after 15 seconds or the like), and then the display 22can enter sleep mode and become blank after a second period of time inwhich no button 224 a, 224 b, 224 c, or 224 d has been actuated (e.g.,after 30 seconds or the like). Thus, the dimming of the display device222 can alert a user viewing the display device 222 when the active area223 of the display device will soon become blank.

Accordingly, when the controller device 200 is connected to the pumpdevice 100, the user is provided with the opportunity to readily monitorinfusion pump operation by simply viewing the user interface 220connected to the pump device 100. Such monitoring capabilities mayprovide comfort to a user who may have urgent questions about thecurrent operation of the pump device 100 (e.g., the user may be unableto receive immediate answers if wearing an infusion pump device havingno user interface attached thereto).

Also, there is no need for the user to carry and operate a separatemodule to monitor the operation of the infusion pump device 100, therebysimplifying the monitoring process and reducing the number of devicesthat must be carried by the user.

If a need arises in which the user desires to monitor the operation ofthe pump device 100 or to adjust settings of the pump system 10 (e.g.,to request a bolus amount of medicine), the user can readily operate theuser interface 220 removably attached to the pump device 100, withoutthe requirement of locating and operating a separate monitoring module.

It should be understood from the description herein that the userinterface 200 is not limited to the display and buttons depicted inFIG. 1. For example, in some embodiments, the user interface 220 mayinclude only one button or may include a numbers of buttons, such as twobuttons, three buttons, five buttons, or more. In another example, theuser interface 220 of the controller device 200 may include touch screenso that a user may select buttons defined by the active area of thetouch screen display. Alternatively, the user interface may compriseaudio inputs or outputs so that a user can monitor the operation of thepump device. Previously incorporated U.S. Provisional Application Ser.No. 60/721,267 also describes a number of configurations for a removablecontroller device and a user interface for the device in addition to theconfiguration illustrated in FIGS. 1-2 herein.

Referring to FIG. 3, the infusion pump system 10 may be configured to beportable and can be wearable and concealable. For example, a user canconveniently wear the infusion pump system 10 on the user's skin (e.g.,skin adhesive) underneath the user's clothing or carry the pump device100 in the user's pocket (or other portable location) while receivingthe medicine dispensed from the pump device 100. As described in moredetail below, the drive system may be housed in the housing structure110 of the pump device 100 in a compact manner so that the pump device100 has a reduced length. For example, in the circumstances in which themedicine cartridge 120 has a length of about 6 cm to about 7 cm (about6.4 cm in this embodiment), the overall length of the pump housingstructure 110 (which contains medicine cartridge and the drive system)can be about 7 cm to about 9 cm (about 8.3 cm or less in thisembodiment). In addition, the pump housing structure 110 may have anoverall height of about 1.5 cm to about 4 cm (about 2.9 cm or less inthis embodiment) and an overall thickness of about 8 mm to about 20 mm(about 14.5 mm or less in this embodiment). In such circumstances, thecontroller device 200 can be figured to mate with the compact pumphousing 110 so that, when removably attached to one another, thecomponents define a portable infusion pump unit that stores a relativelylarge quantity of medicine compared to the overall size of the unit. Forexample, in this embodiment, the infusion pump system 10 (including thepump device 100 attached to the removable controller device 200) mayhave an overall length of about 7 cm to about 9 cm (about 8.5 cm or lessin this embodiment), an overall height of about 1.5 cm to about 4 cm(about 3.5 cm or less in this embodiment), and an overall thickness ofabout 8 mm to about 20 mm (about 15 mm or less in this embodiment).

As shown in FIG. 3, this embodiment of the infusion pump system 10 ispocket-sized so that the pump device 100 and controller device 200 canbe worn in the user's pocket or in another portion of the user'sclothing. In such embodiments, the cap member 115 of the pump device 100may be configured to connect with a flexible tube 119 of an infusionset. The infusion set may include the tube 119 that extends toward askin adhesive patch and connects with an infusion cannula (not shown inFIG. 3). The skin adhesive patch can retain the infusion cannula influid communication with the tissue or vasculature of the patient sothat the medicine dispensed through the tube 119 passes through thecannula and into the user's body. As described below in connection withFIG. 5, the cap member 115 may provide fluid communication between theoutput end 122 (FIG. 1) of the medicine cartridge 120 and the tube 119of the infusion set. In these embodiments, the user can carry theportable infusion pump system 10 (e.g., in the user's pocket, connectedto a belt clip, or adhered to the user's skin) while the tube 119extends to the location in which the skin is penetrated for infusion. Ifthe user desires to monitor the operation of the pump device 100 or toadjust the settings of the infusion pump system 10, the user can readilyaccess the user interface 220 of the controller device 200 without theneed for carrying and operating a separate module.

In other embodiments, the infusion pump system 10 may be configured toadhere to the user's skin directly at the location in which the skin ispenetrated for medicine infusion. For example, a rear surface 102 of thepump device 100 (refer, for example, to FIG. 2) may include a skinadhesive patch so that the pump device 100 is physically adhered to theskin of the user at a particular location. In these embodiments, the capmember 115 may have a configuration in which medicine passes directlyfrom the cap member 115 into an infusion cannula that is penetrated intothe user's skin. Again, if the user desires to monitor the operation ofthe pump device 100 or to adjust the settings of the infusion pumpsystem 10, the user can readily access the user interface 220 of thecontroller device 200 without the need for carrying and operating asecond, separate device. For example, the user may look toward the pumpdevice 100 to view the user interface 220 of the controller device 220that is removably attached thereto.

Referring to FIGS. 4-6, as previously described, the pump device 100 ofthe infusion pump system 10 is configured to removably attached to thecontroller device 200. In this embodiment, the pump device 100 includesa pump housing structure 110, and at least a portion of the pump housingstructure 110 is configured to be received in a complementary cavity 215(FIG. 5) defined in the controller housing structure 210. When the pumpdevice 100 is received by the controller device 200, a retainer finger212 may engage a mating surface of the pump housing structure 110. Inaddition, a magnetic attachment can be used to releasably secure thepump device 100 to any of the controller housing structures 210. In suchcircumstances, the pump device 100 includes one or more magneticallyattractable devices 118 a and 118 b (e.g., permanent magnets in thisembodiment depicted in FIG. 4) exhibited on the front surface 104 of thepump housing structure 110 which magnetically engage complementarydevices 218 a and 218 b (e.g., permanent magnets in this embodimentdepicted in FIG. 5) arranged on the controller housing structure 210. Assuch, when the pump device 100 is received in the cavity 215 defined bythe controller housing structure 210, the magnetically attractabledevices 118 a-b and 218 a-b form a magnetic attachment to retain thepump device 100 therein.

As shown in FIG. 4, the pump device 100 may include one or moreelectrical contacts 149 that provide electrical communication with oneor more components disposed in the pump device 100. Also, as shown inFIG. 5, the controller device 200 may include one or more electricalcontacts 249 that provide electrical communication with one or morecomponents disposed in the controller device 200, such as a controllercircuit 240. The electrical contacts 149 of the pump device 100 arearranged to engage complementary electrical contacts 249 (FIG. 5)positioned on the controller housing structure 210. In this embodiment,the electrical contacts 249 are arranged on the controller housingstructure 210 so as to align with the electrical contacts 149 of thepump device 100 when the pump device 100 is received in the cavity 215of the controller device 200. Accordingly, when the pump device 100 isremovably attached to the controller device 200, the controller device200 becomes electrically connected to the pump device 100 via thecontacts 149 and 249 to provide for the communication of electricalcontrol signals from the controller circuit 240.

Still referring to FIGS. 4-6, the controller circuit 240 of thecontroller device 200 may include a battery 245 and a microcontrollerdevice 246 that coordinates the electrical communication to and from thecontroller device 200. At least a portion of the controller circuit 240can be embodied on a printed circuit board (or a flexible circuitsubstrate). The battery 245 and the microcontroller 246 can be mountedto such a printed circuit board (or connect to such a flexible circuitsubstrate). Electrical connections from the electrical contacts 249 andthe user interface 220 (FIG. 6) may extend along the printed circuitboard to the microcontroller device 246. In this embodiment, thecontroller circuit 240 is disposed in a hollow space of the controllerhousing structure 210. For example, the controller housing structure 210can be formed from two molded portions that are welded or adhered to oneanother after the controller circuit 240 is assembled therein. As shownin FIG. 5, some embodiments of the controller circuit 240 may include acable connector 243 (e.g., a USB connection port or another data cableport). As such, a cable may be connected to the controller circuit 240to upload data or program settings to the controller circuit or todownload data from the controller circuit 240. For example, historicaldata of medicine delivery can be downloaded from the controller circuit240 (via the cable connector 243) to a computer system of a physician ora user for purposes of analysis and program adjustments. Optionally, thedata cable may also provide recharging power to the controller circuit240.

Still referring to FIGS. 4-6, the user interface 220 of the controllerdevice 200 can include input components, output components, or both thatare electrically connected to the controller circuit 240 (FIG. 5). Forexample, in this embodiment, the user interface includes a displaydevice 222 having an active area 223 that outputs information to a userand four buttons 224 a, 224 b, 224 c, and 224 d that receive input fromthe user. Here, the display 222 may be used to communicate a number ofsettings or menu options for the infusion pump system 10. In thisembodiment, the controller circuit 240 may receive the input commandsfrom the user's button selection and thereby cause the display device222 to output a number of menus or program screens that show particularsettings and data (e.g., review data that shows the medicine dispensingrate, the total amount of medicine dispensed in a given time period, theamount of medicine scheduled to be dispensed at a particular time ordate, the approximate amount of medicine remaining the cartridge 120, orthe like). As previously described, the controller circuit 240 can beprogrammable in that the input commands from the button selections cancause the controller circuit 240 to change any one of a number ofsettings for the infusion pump system 100.

Optionally, the controller device 200 may include an indicia (not shownin FIGS. 4-6) that identifies the particular type of medicine cartridge120 or medicine with which it is to be employed. The medicine cartridge120 may include a similar indicia (not shown in FIGS. 4-6). As such, theuser can verify that the appropriate type of medicine is received in thepump device 100 for controlled dispensation by the controller device200. For example, the indicia may include a label, marking, etching, orthe like disposed on the controller housing structure 210 that indicatesa particular name, code, or other identifier corresponding to aparticular medicine 231 (e.g., “EXENATIDE”, “BYETTA”, “INSULIN”, oranother identifier).

Referring now to FIG. 7, the pump device 100 of the infusion pump system10 may include a drive system 105 that is controlled by the removablecontroller device 200. Accordingly, the drive system 105 can accuratelyand incrementally dispense fluid from the pump device 100 in acontrolled manner. In this embodiment, the pump housing structure 110includes a detachable shell 112 that covers at least a portion of thedrive system 105 and includes a frame portion 114 to which at least aportion of the drive system 105 is mounted. The detachable shell 112 mayinclude an inner curved surface against which a curved section of apushrod 170 rests. The detachable shell 112 can be part of the pumphousing structure 110 that engages with the controller device 200 aspreviously described in connection with FIGS. 4-6. As such, thedetachable shell portion 112 may include the magnetically attractabledevices 118 a and 118 b that releasably secure the pump device 100 tothe controller device 200. In addition, the detachable shell 112 mayprovide access to the electrical contacts 149 of the pump device 100. Inthis embodiment, the electrical contacts 149 are configured to alignwith the contact circuit device 148 arranged in the pump device 100. Inother embodiments, the electrical contacts of the pump device 100 can bearranged directly on the contact circuit device 148, and the detachableshell 112 may include a slot (in the location shown as numeral 149) soas to permit electrical engagement with the controller device 200.

One or both of the detachable shell 112 and the frame portion 114 can bemolded from polymer material, such as Polycarbonate, AcrylonitrileButadiene Styrene (ABS), or Acrylic. In this embodiment, the detachableshell portion 112 comprises a generally opaque, moldable material sothat the drive system 105 and other components of the pump device areconcealed from view. The frame portion 114 may include a cylindricalreceiver 113 that defines the space 116 to receive the medicinecartridge 120 (FIG. 2). In some circumstances, at least a portion of thecylindrical receiver 113 is transparent or translucent so that the usermay view the medicine cartridge 120 therein. Such a configurationprovides the user with visual verification of when the medicinecartridge is empty or near empty (e.g., the plunger in the medicinecartridge has been fully advanced). The receiver 113 may also include aconnector to mate with the cap member 115. In this embodiment, theconnector comprises an external thread pattern formed on the receiver113 that mates with an internal thread pattern of the cap member 115.Accordingly, the cap member 115 can be secured to the frame portion 113after the medicine cartridge 120 (FIG. 2) has been received therein. Asshown in FIG. 7, the cap member 115 may include a cartridge penetrator115 a that pierces the output end 122 (FIG. 2) of the medicine cartridge120 when the cap member 115 is mounted to the frame portion 113. Thecartridge penetrator 115 a is in fluid communication with an tubeconnector 115 b, which can be connected to a tube 119 of an infusion setdevice (as previously described in connection with FIG. 3). Aspreviously described, in some embodiments, the fluid cartridge 120 mayoccupy a majority of the length of the pump housing structure 110 (withthe drive system 105 being arranged in a compact manner) so that thepump device 100 is wearable and portable.

Still referring to FIG. 7, some embodiments of the pump device 100include a local pump circuit 140 that includes the contact circuitdevice 148. The local pump circuit 140 may be simple and inexpensive soas to facilitate a low-cost pump device 100 that is disposable. Thelocal pump circuit 140 may comprise a printed circuit board or aflexible circuit that is arranged in the frame portion 114 of the pumpdevice 100. Optionally, the local pump circuit 140 can include a gatewaycircuit device 146 that coordinates the transmission of electricalsignals to or from the contact circuit device 148 and to or fromcomponents of the drive system 105 (e.g., the motor 130 and othercomponents). In some circumstances, the gateway circuit device 146 maybe under the control of and directed by the control circuit 240 in thecontroller device 200. It should be understood that, in otherembodiments, the local pump circuit 140 may be configured to operatewithout the gateway circuit device 146. For example, the control circuitin the removable controller device 200 may communicate via theelectrical contacts directly with a portion of the drive system 105(e.g., direct electrical communication with the motor 130), with one ormore sensors disposed in the pump device 100, and with other componentsof the local pump circuit 140.

Optionally, the local pump circuit 140 may include a battery 145 that iscapable of transmitting electrical energy to the controller device 200when the pump device 100 is removably attached to the controller device200. As such, the battery 145 in the pump device can be used to rechargethe battery 245 (FIG. 5) in the reusable controller device 200. In someembodiments, the local pump circuit 140 may be electrically connected toone or more sensors disposed in the pump device 100. For example, thegateway circuit device 146 of the circuit 140 may be in electricalcommunication (e.g., via one or more electrical wires or electricallyconductive traces) with a force sensor 147 (refer to FIG. 8) arrangedbetween the plunger connector 178 that the plunger 121. The force sensor147 may comprise a force transducer or load cell that is capable ofelectrically communicating an applied force. As such, the force sensor147 can provide feedback signals to the local pump circuit 140 (or tothe control device 200 via the electrical contacts) so as to monitor theforce transmitted to the plunger 121 of the medicine cartridge 120. Suchinformation can be used, for example, to detect if an occlusion existsin the medicine flow path. Other sensors (e.g., a pressure sensor, aflow sensor, a rotation sensor, a displacement sensor, or the like) maybe electrically connected to the pump circuit 140 to provide feedbacksignals to the control device 200 via the electrical contacts.

Referring to FIGS. 7-8, some embodiments of the drive system 105 mayinclude a rotational motor 130 that is coupled to a string member 135,which is used to adjust a ratchet mechanism 150. The ratchet mechanism150 may drive the forward incremental motion of the pushrod 170 so as todispense medicine from the pump device 100. The drive system 105 canprovide a reliable and compact configuration for accurately dispensingthe desired volume of fluid from the pump device 100. Moreover, thedrive system 105 may comprise few, if any, high-cost actuator componentsor electronics, thereby facilitating the relatively low-cost productionof a disposable and reliable pump device 100.

Referring to the drive system 105 in more detail, the rotational motor130 can be used to act upon the string member 135, thereby causing thestring member 135 to adjust a pawl member 152 relative to a ratchet body155 (e.g., a ratchet wheel integrally formed on the worm gear 156 inthis embodiment). In this embodiment, the string member 135 isconfigured in a loop arrangement (e.g., looped around pin structures136, 137, 138, and 139 in this embodiment) so that the string member 135can be twisted or untwisted in response to the motor rotation. In theseembodiments, the motion path of the string member 135 and theorientation of the string member 135 can be configured to provide anefficient mechanical advantage orientation during the desired motion ofthe adjustable pawl member 152. One of the pin structures 138 may becoupled to the adjustable pawl member 152 while the remaining pinstructures 136, 137, and 139 are coupled to the frame portion 114 of thepump device 100. Accordingly, the motor 130 can twist the string toforce the pawl member 152 to a reset position. The spring device 154 candrive the pawl member from the reset position to a forward position (asthe string member is untwisted), which incrementally rotates the ratchetwheel 155. As previously described, incremental rotation of the ratchetwheel 155 causes rotation of a drive wheel 160, which causes theincremental longitudinal advancement of a flexible pushrod 170. Aplunger connector 178 may be coupled to the leading end of the flexiblepushrod 170 so as to abut against or connect with the plunger 121 in theplunger chamber 126 of the fluid cartridge 120. As the pushrod 170 isadvanced into plunger chamber 126 (e.g., defined in this embodiment bythe circumferential wall 124 of the fluid cartridge 120), the fluid inthe cartridge 120 is forced from septum at the output end 122.

As shown in FIG. 8, some components of the drive system 105 can beretained by the frame portion 114, a cover mount 107 that is assembledto the frame portion 114, or a combination thereof. For example, therotational motor 130, the string member 135, and the spring device 154can be assembled into the frame portion 114 and then retained by thecover mount 107. The adjustable pawl member 152, the ratchet wheel 155,and the worm gear 156 can be assembled onto and axle 151 that isintegrally formed with the frame portion 114 and then retained by thecover mount 107. A locking pawl 159 can be integrally formed with theframe portion 114 so as to align with the ratchet wheel 155 when theratchet wheel 155 is assembled onto the axle 151. Also, the drive wheel160 and an adjacent bearing 165 (to facilitate rotation of the drivewheel 160 relative to the frame portion 114) can be received in annularchannels 163 and 167, respectively, of the frame portion 114. When thecover mount 107 is assembled to the frame portion 114, the cover mount107 can restrict the radial or axial movement of the drive wheel 160while permitting forward rotation of the drive wheel 160. In anotherexample, the “unused” or retracted portion of the pushrod 170 may restin a channel 108 defined in the top of the cover mount 107. In such aconstruction, the cover mount 107 and the frame portion 114 cancollectively permit the desired motion of the components of the drivesystem 105 while reducing the likelihood of “backlash” movement orcomponent dislodgement (which might otherwise occur, for example, whenthe pump device 100 is dropped to the ground). Previously incorporatedU.S. Provisional Application Ser. No. 60/720,411 also describes a numberof configurations for the drive system in addition to the illustrativeexample depicted in FIG. 8 herein.

It should be understood that the drive system 105 can employ one or moresensors to indicate when the pawl member 152 has reach the resetposition or the forward position. For example, these sensors can beoptical, magnetic, or contact type sensors. The sensors may be capableof transmitting signals that indicate when the location of the pinstructure 148 or the pawl member 152 is detected. Such sensor signalsmay be transmitted to the first circuit 140, to the controller device200 or 300, or a combination thereof.

In some embodiments, the pushrod 170 may undergo only forward orpositive displacement as a result of drive system 105. For example, thedrive system 105 substantially hinders the pushrod 170 from retractingor “backing up” in response to fluid pressure in the medicine cartridge120 or other reversal forces. In such circumstances, the flexiblepushrod 170 can be retracted only upon disassembly of the pump device100 (e.g., to disengage the gears or the ratchet mechanism). In thoseembodiments in which the pump device 100 is intended to be disposable,the non-retractable pushrod configuration (due to the drive system 105)may facilitate a “one time use” disposable pump device, thereby reducingthe likelihood of failure due to non-intended repeated use of thedisposable pump device.

Referring to FIGS. 9-10, the flexible pushrod 170 may comprise aplurality of segments 172 serially connected by hinge portions 175 sothat the flexible pushrod 170 is adjustable from a curved shape to anoncurved shape. The plurality of segments 172 and the interconnectinghinge portions 175 (FIG. 10) can be integrally formed in one piece froma moldable material, including one or more polymer materials such asNylon or POM. As shown in FIG. 10, each segment 172 is hingedly engagedwith the adjacent, neighboring segment 172. Thus, each segment 172 canpivot away from the adjacent segment 172 so that a portion the flexiblepushrod 170 takes on a curved shape. Also, each segment can pivot towardthe adjacent segments so that a front surface or leading face 171 of onesegment abuts the rear surface or trailing face 179 of the adjacentsegment 179, thereby forming a generally noncurved shape for a portionof the pushrod 170. When the leading face 171 of one segment 172 abutsthe trailing face 179 of the adjacent surface, that portion of thepushrod can become a rigid device to transfer a pushing force.

In this embodiment, the plurality of segments 172 comprise generallycylindrical segments that each include an thread pattern 176 along atleast one cylindrical surface portion 177 (FIG. 10). As described inmore detail below, the thread pattern 176 can engage a mating threadpattern of the drive wheel 160. For example, the thread pattern 176 ofthe pushrod segments 172 may be an external thread pattern that mateswith an internal thread pattern of the drive wheel 160. Accordingly, theincremental rotation of the drive wheel 160 can be translated into anincremental longitudinal motion for the pushrod 170. Previouslyincorporated U.S. Provisional Application Ser. No. 60/720,405 alsodescribes a number of configurations for the flexible pushrod and theengagement with the drive wheel.

Still referring to FIGS. 9-10, the flexible pushrod 170 can include ananti-rotation mechanism that hinders the pushrod 170 from rotating withdrive wheel 160. In this embodiment, the anti-rotation mechanismincludes two longitudinal channels 173 and 174 that engage respectiveprotrusions on the frame portion 114 (refer to FIG. 12), therebyhindering rotation of the pushrod 170 about its longitudinal axis.Because the drive wheel 160 can rotate relative to the pushrod 170(which is substantially prevented from rotating by the anti-rotationmechanism), the rotation of the drive wheel 160 can thereby translateinto the longitudinal motion of the pushrod 170.

Referring now to FIG. 11, the flexible pushrod 170 can include astructure that mates with the drive wheel 160 so as to translate therotation of the drive wheel 160 into a longitudinal motion of thepushrod 170. In this embodiment, the pushrod segments 172 include anexternal thread pattern 176 along some or all of the cylindrical surfaceportion 177. The external thread pattern 176 is capable of mating withan internal thread pattern 166 of the drive wheel 160. As such, rotationof the drive wheel 160 causes the internal thread pattern 166 to meshwith external thread pattern 176 of the pushrod segment, thereby drivingthe pushrod segment in a longitudinal direction. The thread count andangulation of the thread patterns 166 and 176 can be selected to providepredetermined longitudinal advancement distance of the pushrod 170 for agiven increment of rotation of the drive wheel 160. In one example, thedrive system 105 can advance the pushrod 170 a longitudinal advancementdistance of about 16 microns or less (about 4 microns to about 12microns, and preferably about 7 microns to about 8 microns) for eachincremental motion cycle of the motor 130, string member 135, andratchet mechanism 150 as described herein

As shown in FIG. 11, at least a portion of the pushrod 170 that is notyet advanced into engagement with the drive wheel 160 may have a curvedshaped. For example, the hinge portions 175 may be flexed so that afirst segment 172 is pivoted away from the an adjacent second segment172. When a segment 172 is forwardly advanced so as to engage the drivewheel 160, that particular segment 172 may hingedly adjust toward theimmediately forward segment 172. As such, at least a portion of thepushrod 170 that is advanced through the drive wheel 160 may have agenerally straight shape (with the forward most segment 172 pressingagainst the plunger connector 178 (FIG. 8) that presses against theplunger 121 of the medicine cartridge 120 (FIG. 8)). As previouslydescribed, when the portion of the pushrod 170 has a generally straightshape, the leading face 171 of one segment 172 can abut the trailingface 179 of the adjacent segment 174 so as to transfer a pushing force.

Referring to FIG. 12, the anti-rotation mechanism of the flexiblepushrod 170 can interact with the frame portion 114 of the pump device100 so as to hinder rotation of the pushrod 170 during rotation of thedrive wheel 160 (removed from FIG. 12 for purposes of illustration;refer to FIG. 8). In such circumstances, the drive wheel 160 can rotateabout its axis while the anti-rotation mechanism opposes rotation of thepushrod 170 about the longitudinal axis of the pushrod 170. Aspreviously described, in this embodiment, the anti-rotation mechanismcomprises two longitudinal channels 173 and 174, each of which extendthrough the pushrod segments 172 in a generally longitudinal direction.As shown in FIG. 12, the first longitudinal channel 173 can engage acomplementary protrusion 111 a on the frame portion 114 proximate thedrive wheel 160 (not shown in FIG. 12) so that the flexible pushrod 170is hindered from rotating when the drive wheel 160 turns relative to theframe portion 114. In addition, the second longitudinal channel 174 canengage a complementary protrusion 111 b on the frame portion 114proximate the drive wheel so as to further hinder rotation of thepushrod 170 when the drive wheel 160 turns relative to the frame portion114. Accordingly, each longitudinal channel 173 and 174 in the segment172 aligns to form a keyway that receives a mating key (e.g., theprotrusion 111 a or 111 b) on the frame portion 114.

Accordingly, two or more longitudinal channels (oppositely disposedchannels 173 and 174 in this embodiment) may be employed in ananti-rotation mechanism for the pushrod 170. When two channels areemployed (rather than a single channel), the channels may be configuredto have a relatively smaller size while still providing theanti-rotation services. The smaller-sized channels may permit thepushrod segment 172 to slidably engage the protrusions 111 a and 111 bof the frame member 114 with substantially reduced friction. Such areduction in the friction upon the pushrod 170 can reduce the overallload imposed upon the drive system 105 of the pump device.

It should be understood that, as described in more detail below, theanti-rotation mechanism may include one longitudinal channel, threelongitudinal channels, or more longitudinal channels (with each channelcapable of engaging an associated protrusion that acts as a key tohinder rotation while permitting longitudinal motion). Alternatively, asdescribed in more detail below, the anti-rotation mechanism may includeone or more flat surfaces along each segment 172 (with the flat surfaceslidably engaging a complementary flat surface on the frame portion114).

Referring now to FIGS. 13A-B, some embodiments of a flexible pushrod 370for use in the pump device 100 may include an anti-torsion mechanism 380and, optionally, an anti-rotation mechanism (e.g., at least onelongitudinal channel 373 in this embodiment). Similar to previouslydescribed embodiments, the flexible pushrod 370 may comprise a pluralityof segments 372 (only two of the segments 372 are shown in FIG. 13 forpurposes of illustration) serially connected by hinge portions 375 sothat the flexible pushrod 370 is adjustable from a curved shape to anoncurved shape. Thus, each segment 372 can pivot toward or away fromthe adjacent segment 372 so that a portion the flexible pushrod 370takes on a curved shape or a noncurved shape. As shown in FIG. 13B, theanti-torsion mechanism 380 may oppose torsion of one rod segment 372relative to its adjacent rod segment 372. By opposing such torsion, theanti-torsion mechanism 380 can resist the torsion across the hingeportions 375 that would otherwise occur from the twisting motion of onesegment 372 a relative to the adjacent segment 372 b.

Similar to previously described embodiments, the plurality of segments372 may comprise a thread pattern 376 along at least one cylindricalsurface portion 377, and the thread pattern 376 is configured to engagea mating thread pattern of the drive wheel (e.g., similar to drive wheel160 depicted in FIGS. 8 and 11). Accordingly, the incremental rotationof the drive wheel 160 (FIG. 8) can be translated into an incrementallongitudinal motion for the pushrod 370. As previously described, when asegment 372 is forwardly advanced through the drive wheel 160, thesegment 372 adjusts toward the immediately forward segment 372 so that aleading face 371 of one segment 372 abuts the trailing face 379 of theadjacent segment 372.

Referring to FIG. 13B, in some circumstances, the rotation of the drivewheel 160 may urge the currently engaged segment 372 a to twist relativeto the forward segment 372 b that is substantially rigidly pressedagainst the piston connector 178 (FIG. 8) and the piston 121 (FIG. 8).This twisting bias of the rearward segment 372 s relative to theadjacent forward segment 372 b may create a torsion (refer, for example,to the illustrative arrows in FIG. 13B) across the interconnecting hingeportion 375. Accordingly, the pushrod 370 may be equipped with ananti-torsion mechanism 380 to resist such relative torsion. Theanti-torsion mechanism 380 can include an extension member (e.g., member382) that extends from one segment into a mating cavity (e.g., cavity383) of the adjacent segment when the two segments are adjusted to agenerally straight or rigid condition. For example, in this embodiment,the anti-torsion mechanism 380 may include an integrally formedprotrusion 382 that extends from the leading face 371 of a first segment372. Also in this embodiment, the anti-torsion mechanism 380 includes acavity 383 formed in the trailing face 379 of a second adjacent segment372. As shown in FIG. 13B, the cavity 383 is configured to mate with theprotrusion 382 when this portion of the pushrod 370 is adjusted to arigid condition in which the leading face 371 of the first segment 372 aabuts with the trailing face 379 of the adjacent forward segment 372 b.

Such an engagement of the components of the anti-torsion mechanism 380enables the flexible pushrod 370 to hinder the twisting motion of thefirst segment 372 a relative to the adjacent segment 372 b. Accordingly,the anti-torsion mechanism may oppose torsion of one rod segment 372relative to its adjacent rod segment 372. By opposing such torsion, theanti-torsion mechanism 380 can resist the torsion across the hingeportions 375 that would otherwise occur from the twisting motion of onesegment 372 a relative to the adjacent segment 372 b.

Optionally, in addition to the anti-torsion mechanism 380, the flexiblepushrod 370 can include an anti-rotation mechanism that hinders thepushrod 370 from rotating with drive wheel 160. Thus, while theanti-rotation mechanism hinders rotation of the pushrod 370 relative tothe frame portion 114 (e.g., rotation with the drive wheel 160), theanti-torsion mechanism 380 can resist torsion one pushrod segment 372 arelative to an adjacent segment 372 b. In this embodiment, theanti-rotation mechanism includes two longitudinal channels (only onechannel 373 is shown in the view in FIG. 13A) that engage respectiveprotrusions on the frame portion 114 (as previously described inconnection with FIG. 12). Because the drive wheel 160 can rotaterelative to the pushrod 370 (which is substantially prevented fromrotating by the anti-rotation mechanism), the rotation of the drivewheel 160 can thereby translate into the longitudinal motion of thepushrod 370.

Referring again to FIG. 13B, some embodiments of the flexible pushrod370 for use in the pump device 100 may include an anti-elongationmechanism 379 to maintain the pushrod segments 372 in an abuttingrelationship after adjusting to the rigid and generally non-curvedshape. For example, the anti-elongation mechanism 379 may comprise apressure-sensitive adhesive disposed on the trailing face 379 of thepushrod segments 372, on the leading face 371 of the pushrod segments372, or on both the leading and trailing faces 371 and 379 of thepushrod segments 372. Accordingly, when the trailing segment 372 a ispivoted about the hinge portion 375 toward the forward segment 372 b,the pushrod segments 372 a and 372 b abut against one another and aremaintained in the abutted condition by the pressure-sensitive adhesive389. Because the segments 372 a and 372 b are urge in the longitudinaldirection toward the piston 121 in the medicine cartridge 120, thepressure between the segments 372 a and 372 b is sufficient to activatethe pressure-sensitive adhesive 389. Also, in some embodiments, thepressure sensitive adhesive may serve as an anti-torsion mechanism thatopposes torsion of one rod segment 372 a relative to its adjacent rodsegment 372 b.

Such an engagement of the first segment 372 a relative to the adjacentsegment 372 b serves to hinder elongation of the portion of the pushrod370 that is being forced against the plunger 121. If, for example, thepump device 100 was dropped on the ground, the plunger 121 in themedicine cartridge may be maintained in a substantially stationaryposition relative to the pushrod 370 because the pushrod segments 372 aand 372 b are maintained in the rigid and generally non-curved shape. Ifthe portion of the pushrod 370 that is being pushed against the plunger121 is permitted to elongate (e.g., if the segments 372 a and 372 b inFIG. 13B shift to the disengaged orientation shown in FIG. 13A), theplunger 121 may possibly shift inside the medicine cartridge 120 andincidentally dispense some medicine. Accordingly, the anti-elongationmechanism may maintain of the pushrod segments 372 a and 372 in theabutting relationship after that portion of the pushrod 370 has beenadjust to the rigid and generally non-curved shape.

It should be understood that the anti-elongation mechanism is not limitto the pressure-sensitive adhesive 389 depicted in FIG. 13B. Forexample, the anti-elongation mechanism may by incorporated into theanti-torsion mechanism 380 (FIG. 13A). In such embodiments, theanti-elongation mechanism may comprise one or more geometric structures(e.g., a hemispherical extension or the like) that extends from one orboth of the lateral sides of the protrusion 382 as to snap into and lockwith a mating socket (e.g., a corresponding hemi-sperical socket)defined in the cavity 383. In an alternative embodiment, theanti-elongation mechanism may comprise a pressure sensitive adhesive(like adhesive 389 in FIG. 13B) that is disposed on the protrusion 382of the anti-torsion mechanism 380, on the surface of the cavity 382 ofthe anti-torsion mechanism 380, or both. In these embodiments,anti-elongation mechanism can maintain of the pushrod segments 372 a and372 in the abutting relationship after that portion of the pushrod 370has been adjust to the rigid and generally non-curved shape.

Referring now to FIG. 14, some embodiments of a flexible pushrod 470 foruse in the pump device 100 may include hinge portions 475 that are notintegral with the material of the pushrod segments 472. For example, inthis embodiment, the hinge portions 475 may comprise a flexible wirethat is integrally molded with or assembled into the segments 472 of thepushrod 470. Similar to previously described embodiments, the flexiblepushrod 470 comprises a plurality of segments 472 (only two of thesegments 472 are shown in FIG. 14 for purposes of illustration) seriallyconnected by the hinge portions 475 so that the flexible pushrod 470 isadjustable from a curved shape to a noncurved shape. Because the hingeportions comprise a flexible wire configuration, each segment 472 canpivot toward or away from the adjacent segment 472 so that a portion theflexible pushrod 470 takes on a curved shape or a noncurved shape.

Similar to previously described embodiments, the plurality of segments472 may comprise a thread pattern 476 along at least one cylindricalsurface portion 477. The thread pattern 476 is configured to engage amating thread pattern of the drive wheel (e.g., similar to drive wheel160 depicted in FIGS. 8 and 11). Accordingly, the incremental rotationof the drive wheel 160 (FIG. 8) can be translated into an incrementallongitudinal motion for the pushrod 470. As previously described, when asegment 472 is forwardly advanced through the drive wheel 160, thesegment 472 adjusts toward the immediately forward segment 472 so that aleading face 471 of one segment 472 abuts the trailing face 479 of theadjacent segment 472. Optionally, the flexible pushrod 470 can includean anti-rotation mechanism that hinders the pushrod 470 from rotatingwith drive wheel 160 (FIG. 8). In this embodiment, the anti-rotationmechanism includes two longitudinal channels (only one channel 473 isshown in the view in FIG. 14) that engage respective protrusions on theframe portion 114 (as previously described in connection with FIG. 12).

Still referring to FIG. 14, the plurality of segments 472 can be formedfrom a moldable material, including one or more polymer materials suchas Nylon or POM. During the molding process, a flexible wire comprisinga metallic material (e.g., stainless steel, superelastic Nitinolmaterial, or the like) can be placed into the mold. As such, themetallic wire can be integrally molded with the pushrod segments 472 soas to form a one-piece flexible pushrod 470. In such embodiments, thepushrod segments 472 are interconnected by hinge portions 475 thatinclude the flexible wire material. In this embodiment, the hingeportions 475 between the plurality of segments 472 in the pushrodinclude the same flexible wire piece. It should be understood that, insome embodiments, each individual hinge portion may include anindividual flexible wire that is separate from other hinge portions 475of the pushrod 470.

In some embodiments, the flexible pushrod 470 may include ananti-elongation mechanism that maintains of the pushrod segments 472 inan abutting relationship after that portion of the pushrod 470 has beenadjust to the rigid and generally non-curved shape. For example, similarto the embodiments previously described in connection with FIG. 13B, theanti-elongation mechanism may comprise a pressure-sensitive adhesivedisposed on the trailing face 479 or leading face 471 of the pushrodsegments 472.

Referring now to FIG. 15, some embodiments of a flexible pushrod 570 foruse in the pump device 100 may include hinge portions 575 that include aflexible wire material and may include an anti-torsion mechanism 580.Similar to embodiments previously described in connection with FIGS.13A-B, the anti-torsion mechanism 580 may resist the torsion across thehinge portions 575 that would otherwise occur from the twisting motionof one segment 572 relative to the adjacent segment 572.

In this embodiment, the hinge portions 575 comprise a flexible wire thatis integrally molded with or assembled into the segments 572 of thepushrod 570. A plurality of the pushrod segments 572 (only two of thesegments 572 are shown in FIG. 15 for purposes of illustration) seriallyconnected by the hinge portions 575 so that the flexible pushrod 570 isadjustable from a curved shape to a noncurved shape. Similar topreviously described embodiments, the plurality of segments 572 maycomprise a thread pattern 576 along at least one cylindrical surfaceportion 577. The thread pattern 576 is configured to engage a matingthread pattern of the drive wheel (e.g., similar to drive wheel 160depicted in FIGS. 8 and 11). Accordingly, the incremental rotation ofthe drive wheel 160 (FIG. 8) can be translated into an incrementallongitudinal motion for the pushrod 570.

As shown in FIG. 15, the pushrod 570 may be equipped with ananti-torsion mechanism 580 to resist relative twisting motion betweenadjacent segments 572. Similar to embodiments previously described inconnection with FIGS. 13A-B, the anti-torsion mechanism 580 can includean integrally formed protrusion 582 that extends from the leading face571 of a first segment 572. Also in this embodiment, the anti-torsionmechanism 580 also includes a cavity 583 formed in the trailing face 579of a second adjacent segment 572. The cavity 583 is configured to matewith the protrusion 582 when this portion of the pushrod 570 is adjustedto a rigid condition in which the leading face 571 of the first segment572 abuts with the trailing face 579 of the adjacent forward segment572. As previously described, such an engagement of the components ofthe anti-torsion mechanism 580 enables the flexible pushrod 570 tohinder the twisting motion of the first segment 572 relative to theadjacent segment 572. Accordingly, the anti-torsion mechanism 580 mayoppose torsion of one rod segment 572 relative to its adjacent rodsegment 572. By opposing such torsion, the anti-torsion mechanism 580can resist the torsion stresses that might ordinarily occur across thehinge portion 575.

Optionally, in addition to the anti-torsion mechanism 580, the flexiblepushrod 570 can include an anti-rotation mechanism that hinders thepushrod 570 from rotating with drive wheel 160 (FIG. 8). In thisembodiment, the anti-rotation mechanism includes two longitudinalchannels (only one channel 573 is shown in the view in FIG. 15) thatengage respective protrusions on the frame portion 114 (as previouslydescribed in connection with FIG. 12). Because the drive wheel 160 canrotate relative to the pushrod 570 (which is substantially preventedfrom rotating by the anti-rotation mechanism), the rotation of the drivewheel can thereby translate into the longitudinal motion of the pushrod570.

In some embodiments, the flexible pushrod 570 may include ananti-elongation mechanism that maintains of the pushrod segments 572 inan abutting relationship after that portion of the pushrod 570 has beenadjust to the rigid and generally non-curved shape. For example, similarto the embodiments previously described in connection with FIG. 13B, theanti-elongation mechanism may comprise a pressure-sensitive adhesivedisposed on the trailing face 579 or leading face 571 of the pushrodsegments 572 or may be incorporated into the anti-torsion mechanism 580.

Referring to FIG. 16, some embodiments of a flexible pushrod 670 for usein the pump device 100 may include hinge portions 690 that can beassembled to interconnect pushrod segments 672. For example, in thisembodiment, the hinge portions 690 may comprise a snap hinge assemblythat includes a hinge protrusion 692 (FIGS. 16 and 17A) on one segment672 connectable with a receiver cavity 696 (FIGS. 16 and 17B) on anadjacent segment 672. The plurality of segments 672 (only two of thesegments 672 are shown in FIG. 16 for purposes of illustration) seriallyconnected by the respective snap hinge assemblies 690 so that theflexible pushrod 670 is adjustable from a curved shape to a noncurvedshape. Similar to previously described embodiments, the plurality ofsegments 672 may comprise a thread pattern 676 along at least onecylindrical surface portion 677. The thread pattern 676 is configured toengage a mating thread pattern of the drive wheel (e.g., similar todrive wheel 160 depicted in FIGS. 8 and 11). Accordingly, theincremental rotation of the drive wheel 160 (FIG. 8) can be translatedinto an incremental longitudinal motion for the pushrod 670. Similar topreviously described embodiments, when a segment 672 is forwardlyadvanced through the drive wheel 160, the segment 672 adjusts toward theimmediately forward segment 672 so that a leading face 671 of onesegment 672 abuts the trailing face 679 of the adjacent segment 672.

Referring to FIG. 16 and to FIGS. 17A-B, the plurality of segments 672can be formed from a moldable material, including one or more polymermaterials such as Nylon or POM, and then assembled together using thesnap hinge assemblies 690. For example, the hinge protrusion 692 ofhinge assembly 690 can be inserted into the mating cavity 696 of theadjacent pushrod segment 672 so that the two segments 672 are hingedlyengaged with one another. As shown in FIG. 17A, the hinge protrusion 692may include an extension body 693 that extends from the leading face 671of the first pushrod segment 672. In this embodiment, locking structures694 in the form of opposing semi-spherical orbs may extend laterallyfrom extension body 693. As shown in FIG. 17B, the mating cavity 696extending into the trailing face 679 of the pushrod segment 672 mayinclude sockets 697 therein to receive the locking structures 694 of thehinge protrusion 692. Accordingly, the hinge protrusion 692 (FIG. 17A)can be inserted into the mating cavity 696 (FIG. 17B) so that thelocking structures 694 snap into engagement with the sockets 697,thereby providing the hinged coupling between the two segments 672.

Referring again to FIG. 16, the pushrod 670 may be equipped with ananti-torsion mechanism 680 to resist relative twisting motion betweenadjacent segments 672. Similar to embodiments previously described inconnection with FIGS. 13A-B, the anti-torsion mechanism 680 can includean integrally formed protrusion 682 that extends from the leading face671 of a first segment 672. Also in this embodiment, the anti-torsionmechanism 680 also includes a cavity 683 formed in the trailing face 679of a second adjacent segment 672. The cavity 683 is configured to matewith the protrusion 682 when this portion of the pushrod 670 is adjustedto a rigid condition in which the leading face 671 of the first segment672 abuts with the trailing face 679 of the adjacent forward segment672. As previously described, such an engagement of the components ofthe anti-torsion mechanism 680 enables the flexible pushrod 670 tohinder the twisting motion of the first segment 672 relative to theadjacent segment 672. Accordingly, the anti-torsion mechanism 680 mayoppose torsion of one rod segment 672 relative to its adjacent rodsegment 672. By opposing such torsion, the anti-torsion mechanism 680can resist the torsion stresses that might ordinarily occur across thehinge portion 675.

Optionally, in addition to the anti-torsion mechanism 680, the flexiblepushrod 670 can include an anti-rotation mechanism that hinders thepushrod 670 from rotating with drive wheel 160 (FIG. 8). In thisembodiment, the anti-rotation mechanism includes two longitudinalchannels (only one channel 673 is shown in the view in FIG. 16) thatengage respective protrusions on the frame portion 114 (as previouslydescribed in connection with FIG. 12). Because the drive wheel 160 canrotate relative to the pushrod 670 (which is substantially preventedfrom rotating by the anti-rotation mechanism), the rotation of the drivewheel can thereby translate into the longitudinal motion of the pushrod670.

In some embodiments, the flexible pushrod 670 may include ananti-elongation mechanism that maintains of the pushrod segments 672 inan abutting relationship after that portion of the pushrod 670 has beenadjust to the rigid and generally non-curved shape. For example, similarto the embodiments previously described in connection with FIG. 13B, theanti-elongation mechanism may comprise a pressure-sensitive adhesivedisposed on the trailing face 679 or leading face 671 of the pushrodsegments 672 or may be incorporated into the anti-torsion mechanism 680.

Referring now to FIG. 18, some embodiments of a flexible pushrod 770 foruse in the pump device 100 may include an anti-rotation mechanism otherthan longitudinal channels. For example, the flexible pushrod 770 mayinclude one or more generally flat lateral faces (e.g., opposing flatfaces 773 and 774 are included in this embodiment). In suchcircumstances, the generally flat lateral faces 773 and 774 can engagecomplementary flat walls on the frame portion 114 (rather than theprotrusions 111 a and 111 b previously described in connection with FIG.12).

Similar to previously described embodiments, the flexible pushrod 770may comprise a plurality of segments 772 serially connected by hingeportions 775 so that the flexible pushrod 770 is adjustable from acurved shape to a noncurved shape. Thus, each segment 772 can pivottoward or away from the adjacent segment 772 so that a portion theflexible pushrod 770 takes on the curved shape or the noncurved shape.The plurality of segments 772 may comprise a thread pattern 776 along atleast one cylindrical surface portion 777. Similar to previouslydescribed embodiments, the thread pattern 776 may be configured toengage a mating thread pattern of the drive wheel (e.g., similar todrive wheel 160 depicted in FIGS. 8 and 11). Accordingly, theincremental rotation of the drive wheel 160 (FIG. 8) can be translatedinto an incremental longitudinal motion for the pushrod 770. Aspreviously described, when a segment 772 is forwardly advanced throughthe drive wheel 160, the segment 772 adjusts toward the immediatelyforward segment 772 so that a leading face 771 of one segment 772 abutsthe trailing face 779 of the adjacent segment 772.

Still referring to FIG. 18, the lateral faces 773 and 774 of theanti-rotation mechanism can be used to hinder the pushrod 770 fromrotating with drive wheel 160 (FIGS. 8 and 11). In such circumstances,the drive wheel 160 can rotate about its axis while the anti-rotationmechanism opposes rotation of the pushrod 770 about the longitudinalaxis of the pushrod 770. In this embodiment, the lateral faces 773 and774 comprise generally flat lateral sides formed in the thread pattern776 of each pushrod segment 772. As such, the thread pattern 776 on eachsegment 772 may be discontinuous. In this embodiment, the generally flatlateral sides formed in the thread pattern 776 may be formed into alateral section of the thread pattern 776 that reaches to the depth ofthe cylindrical surface portion 777. Accordingly, in this embodiment,the lateral faces 773 and 774 do not cut substantially into thecylindrical body of the segment 772, but instead are generally definedalong the flat sides of the thread pattern 776. In such circumstances,the generally flat lateral faces 773 and 774 can engage complementaryflat walls on the frame portion 114 (rather than the protrusions 111 aand 111 b previously described in connection with FIG. 12). Because thedrive wheel 160 (FIGS. 8 and 11) can rotate relative to the pushrod 770(which is substantially prevented from rotating by the anti-rotationmechanism), the rotation of the drive wheel 160 can thereby translateinto the longitudinal motion of the pushrod 770. It should be understoodthat, in some embodiments, the lateral faces 773 and 774 may be formedto a depth that cuts into the cylindrical body of the segment 772 andinto the thread pattern 776.

Optionally, in addition to the anti-rotation mechanism, the flexiblepushrod 770 can include an anti-torsion mechanism to resist suchrelative twisting motion between adjacent rod segments 772. In suchcircumstances, the anti-torsion mechanism may include protrusions thatengage mating cavities as previously described in connection with FIGS.13A-B. Thus, the anti-torsion mechanism of the flexible pushrod 770 canresist the torsion stresses that might ordinarily occur across the hingeportion 775.

In some embodiments, the flexible pushrod 770 may include ananti-elongation mechanism that maintains of the pushrod segments 772 inan abutting relationship after that portion of the pushrod 770 has beenadjust to the rigid and generally non-curved shape. For example, similarto the embodiments previously described in connection with FIG. 13B, theanti-elongation mechanism may comprise a pressure-sensitive adhesivedisposed on the trailing face 779 or leading face 771 of the pushrodsegments 772.

Referring now to FIGS. 19-20, some embodiments of a flexible pushrod 870for use in the pump device 100 may include an anti-rotation mechanismthat includes a combination of one or more longitudinal channels and oneor more flat lateral side. In this embodiment, the anti-rotationmechanism of the flexible pushrod 870 includes one longitudinal channel873 and is formed in one generally flat lateral face 874. In suchcircumstances, one or both of the longitudinal channel 873 or thegenerally flat lateral face 874 can engage complementary structure fixedto the frame portion 114.

Similar to previously described embodiments, the flexible pushrod 870may comprise a plurality of segments 872 serially connected by hingeportions 875 so that the flexible pushrod 870 is adjustable from acurved shape to a noncurved shape. For example, each segment 872 canpivot toward or away from the adjacent segment 872 so that a portion theflexible pushrod 870 takes on the curved shape or the noncurved shape.The plurality of segments 872 may comprise a thread pattern 876 along atleast one cylindrical surface portion 877. Similar to previouslydescribed embodiments, the thread pattern 876 may be configured toengage a mating thread pattern 866 (FIG. 20) of the drive wheel 860.Accordingly, the incremental rotation of the drive wheel 860 can betranslated into an incremental longitudinal motion for the pushrod 870.In this embodiment, the drive wheel 860 may include a fixed portion 814that can be mounted to the frame portion 114 of the pump device 100.Similar to previously described embodiments, when a segment 872 isforwardly advanced through the drive wheel 860, the segment 872 adjuststoward the immediately forward segment 872 so that a leading face 871 ofone segment 872 abuts the trailing face 879 of the adjacent segment 872.

Still referring to FIGS. 19-20, one or both of the longitudinal channel873 or the lateral side 874 can be used to hinder the pushrod 870 fromrotating with drive wheel 860. In this embodiment, the lateral face 874of the anti-rotation mechanism is formed to a depth that cuts into boththe thread pattern 876 and the cylindrical body of each rod segment 872.As such, the thread pattern 876 on each segment 872 may bediscontinuous. In such circumstances, the generally flat lateral face874 can engage a complementary flat wall 817 on the fixed portion 814that is mounted to the frame of the pump device 100. In addition, thelongitudinal channel 873 of the anti-rotation mechanism can engageprotrusion 811 a on the fixed portion 814 (mounted to the frame of thepump device 100). Because the drive wheel 860 can rotate relative to thepushrod 870 (which is substantially prevented from rotating by theanti-rotation mechanism), the rotation of the drive wheel 860 canthereby translate into the longitudinal motion of the pushrod 870. Itshould be understood that, in some embodiments, the flexible pushrod 870may include two opposing longitudinal channels 873 that are formedrespectively in two opposing lateral faces 874.

Optionally, in addition to the anti-rotation mechanism, the flexiblepushrod 870 can include an anti-torsion mechanism to resist suchrelative twisting motion between adjacent rod segments 872. In suchcircumstances, the anti-torsion mechanism may include protrusions thatengage mating cavities as previously described in connection with FIGS.13A-B. Thus, the anti-torsion mechanism of the flexible pushrod 870 canresist the torsion stresses that might ordinarily occur across the hingeportion 875.

In some embodiments, the flexible pushrod 870 may include ananti-elongation mechanism that maintains of the pushrod segments 872 inan abutting relationship after that portion of the pushrod 870 has beenadjust to the rigid and generally non-curved shape. For example, similarto the embodiments previously described in connection with FIG. 13B, theanti-elongation mechanism may comprise a pressure-sensitive adhesivedisposed on the trailing face 879 or leading face 871 of the pushrodsegments 872.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

1. An infusion pump system for the delivery of medication, including: apump housing defining a space to receive a medication; and a drivesystem to dispense medicine when the medicine is received by the pumphousing, the drive system including a pushrod that is movable to apply adispensing force to dispense medicine, the pushrod including rodsegments, each rod segment being interconnected to the next rod segmentby a hinge portion so that at least a portion of the pushrod isadjustable from a curved shape to a generally noncurved shape, whereineach of the hinge portions comprises a flexible wire that extends from aleading face of one rod segment to a trailing face of an adjacent rodsegment.
 2. The system of claim 1, wherein flexible wire is a continuouswire extending between the rod segments.
 3. The system of claim 1,wherein flexible wire comprises a first material, and the pushrodsegments comprise a second, moldable material.
 4. The system of claim 3,wherein the flexible wire comprises a metallic material that isintegrally molded into the pushrod segments.
 5. The system of claim 1,wherein the pushrod further comprises an anti-rotation mechanism tooppose rotation of the pushrod relative to the pump housing.
 6. Thesystem of claim 5, wherein the anti-rotation mechanism comprises twooppositely disposed longitudinal channels, each of the oppositelydisposed longitudinal channels engaging a complementary protrusion thatis fixedly coupled to the pump housing.
 7. The system of claim 1,wherein the pushrod further comprises an anti-torsion mechanism tooppose torsion of one rod segment relative to an adjacent rod segment.8. The system of claim 7, wherein the anti-torsion mechanism comprisesan extension structure protruding from the one rod segment and a matingcavity disposed in the adjacent rod segment, the extension structureprotruding from the one rod segment being received into the matingcavity of the adjacent rod segment when at least a portion of thepushrod is adjusted to the generally noncurved shape.
 9. An infusionpump system for the delivery of medication, comprising: a pump housingdefining a space to receive a medication cartridge; and a drive systemto dispense medicine when the medicine is received by the pump housing,the drive system including a pushrod that is movable to apply adispensing force to dispense medicine, the pushrod includingmechanically assembled rod segments, each rod segment including a hingeprotrusion that pivotably engages a hinge receiver cavity of the nextrod segment in the row by a hinge assembly so that at least a portion ofthe pushrod is adjustable from a curved shape to a generally noncurvedshape.
 10. The system of claim 9, wherein the hinge protrusion and thehinge receive cavity provide a snap hinge assembly.
 11. The system ofclaim 9, wherein the hinge protrusion includes at least one lockingstructure that mates with a socket in the hinge receiver cavity.
 12. Thesystem of claim 9, wherein the pushrod further comprises ananti-rotation mechanism to hinder rotation of the pushrod relative tothe pump housing.
 13. The system of claim 12, wherein the anti-rotationmechanism comprises two oppositely disposed longitudinal channels, eachof the oppositely disposed longitudinal channels engaging acomplementary protrusion that is fixedly coupled to the pump housing.14. The system of claim 9, wherein the pushrod further comprises ananti-torsion mechanism to oppose torsion of one rod segment relative toits adjacent rod segment.
 15. The system of claim 14, wherein theanti-torsion mechanism comprises an extension structure protruding fromthe one rod segment and a mating cavity disposed in the adjacent rodsegment, the extension structure protruding from the one rod segmentbeing received into the mating cavity of the adjacent rod segment whenat least a portion of the pushrod is adjusted to the generally noncurvedshape.